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Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement TherapyPhase 2SBR759NCT00704483

Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

A Phase 2 study testing SBR759 and Sevelamer HCl in people with Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy, run by Novartis Pharmaceuticals at 66 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SBR759 and Sevelamer HCl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
66 sitesin 13 countries
Study dates
Jul 2008to Aug 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women of at least 18 years old.
  • Stable maintenance of renal replacement therapy 3 times per week.
  • Controlled Serum phosphate if under phosphate-binder therapy.
  • Serum phosphate level ≥ 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.

Who cannot join

  • Peritoneal dialysis.
  • Parathyroidectomy or transplant scheduled during the study.
  • Uncontrolled hyperparathyroidism
  • History of hemochromatosis or ferritin > 1000 µg/L.
  • Clinically significant GI disorder
  • Unstable medical condition other than Chronic Kidney Disease.
  • Treated with oral iron.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

66 sites in 13 countries.

66 sites in 13 countries

United States19 sites

  • Novartis

    Baltimore, Maryland, 21287

  • Novartis

    Chula Vista, California, 91910

  • Novartis

    Denver, Colorado, 80262

  • Novartis

    Fairfax, Virginia, 22031

  • Novartis

    Fall River, Massachusetts, 02720

  • Novarits

    Fargo, North Dakota, 58103

  • Novartis Investigative Site

    Houston, Texas, 77024

  • Novartis

    La Mesa, California, 91942

  • Novartis

    Mishawaka, Indiana, 46545

  • Novartis

    New York, New York, 10032

  • Novartis

    North Chicago, Illinois, 60064

  • Novartis Investigative Site

    Omaha, Nebraska, 68144

  • Novartis

    Peoria, Illinois, 61602

  • Novartis

    Pittsburgh, Pennsylvania, 15224

  • Novartis

    Portland, Oregon, 97210

  • Novartis

    San Antonio, Texas, 78207

  • Novartis

    Springfield, Massachusetts, 01104

  • Novartis

    Whittier, California, 90602

  • Novartis

    Winston-Salem, North Carolina, 27157-1082

Other trials in United States

Australia6 sites

  • Novartis

    Adelaide, South Australia

  • Novartis

    Fitzroy, Victoria

  • Novartis

    Melbourne, 3065

  • Novartis

    Parkville, Victoria, 3052

  • Novartis

    South Brisbane

  • Novartis

    Woolloongabba, 4102

Other trials in Australia

Belgium5 sites

  • Novartis Investigative Site

    Antwerp

  • Novartis

    Bruges, 8000

  • Novartis

    Brussels, 1000

  • Novartis

    Liège, 4000

  • Novartis Investigative Site

    Saint Niklaas

Other trials in Belgium

France5 sites

  • Novartis

    Amiens, 80054

  • Novartis

    Fleury-Mérogis

  • Novartis

    Lyon, 69446

  • Novartis

    Reims, 51685

  • Novartis

    Salouël, 80480

Other trials in France

Italy5 sites

  • Novartis Investigative Site

    Lecco

  • Novartis Investigative Site

    Lodi

  • Novartis Investigative Site

    Milan

  • Novartis Investigative Site

    Modena

  • Novartis Investigative Site

    Pavia

Other trials in Italy

Canada4 sites

  • Novartis Investigative Site

    Edmonton

  • Novartis Investigative Site

    London

  • Novartis Investigative Site

    Oshawa

  • Novartis Investigative Site

    Québec

Other trials in Canada

Finland4 sites

  • Novartis

    Helsinki, 00100

  • Novartis

    Oulu, 90100

  • Novartis

    Tampere, 33100

  • Novartis

    Turku, 20100

Other trials in Finland

Norway4 sites

  • Novartis

    Bergen, 5011

  • Novartis

    Kristiansand, 1001

  • Novartis

    Oslo, 0027

  • Novartis

    Tønsberg

Other trials in Norway

Sweden4 sites

  • Novartis Investigative Site

    Jönköping

  • Novartis Investigative Site

    Karlstad

  • Novartis Investigative Site

    Skövde

  • Novartis Investigative Site

    Stockholm

Other trials in Sweden

United Kingdom4 sites

  • Novartis

    Hull

  • Novartis Investigative Site

    Manchester

  • Novartis Investigative Site

    Portsmouth

  • Novartis

    Salford

Other trials in United Kingdom

Switzerland3 sites

  • Novartis

    Aarau, 5000

  • Novartis

    Lausanne, 1011

  • Novartis

    Zurich, 8091

Other trials in Switzerland

Germany2 sites

  • Novartis Investigative Site

    Berlin

  • Novartis Investigative Site

    Coburg

Other trials in Germany

Puerto Rico1 site

  • Novartis

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

Being tested
SBR759, Sevelamer HCl
Keywords
Chronic Kidney Disease, hemodialysis, hyperphosphatemia, hemodiafiltration
Medical subject headings
Renal Insufficiency, Chronic, Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBR759Drug

    Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.

  • Sevelamer HClDrug

    0.8 g tid

  • SBR759Drug

    1.5 g tid

  • Sevelamer HClDrug

    1.6 g tid

Study groups in NCT00704483
Study groupRoleWhat they receive
1Experimental1g tid
Receives: Drug: SBR759
2Active comparatorSevelamer HCl
Receives: Drug: Sevelamer HCl
3ExperimentalSBR759 1.5 g tid
Receives: Drug: SBR759
4Active comparatorSevelamer HCl
Receives: Drug: Sevelamer HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks

    Measured: Time Frame: 12 weeks + 12 months

Secondary outcomes (1)

  1. Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months

    Measured: Time Frame: 12 weeks / 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704483
Sponsor's protocol ID
CSBR759A2201
Other IDs
EUDRACT No.: 2006-001787-23
Acronym
SBR759
Status last verified
Nov 2016
First submitted
23 Jun 2008
Last updated
19 Dec 2020
Results posted
No

Publications

  • Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.

    PubMed 21854503

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBR759 and Sevelamer HCl in people with Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy, run by Novartis Pharmaceuticals at 66 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Australia, Belgium, France, Italy and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks (time frame: Time Frame: 12 weeks + 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00704483, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.

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